Efficacy and Utility of Cxbladder Tests in Hematuria Patients
- Conditions
- HematuriaUrothelial Carcinoma
- Interventions
- Diagnostic Test: Cxbladder
- Registration Number
- NCT04943380
- Lead Sponsor
- Pacific Edge Limited
- Brief Summary
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
- Detailed Description
Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.
The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 684
- Patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/TURBT), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
- Able to provide a voided urine sample of the required minimum volume
- Able to give written consent
- Able and willing to comply with study requirements
- Aged 18 years or older
- Prior history of bladder malignancy, prostate or renal cell carcinoma
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
- Previous alkylating based chemotherapy
- Known Pregnancy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with hematuria undergoing investigation for UC Cxbladder Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as \> 3 red blood cells per high-powered microscopy field for a properly collected urine sample.
- Primary Outcome Measures
Name Time Method Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively. Time Frame: The outcome measure will be assessed by 6 months after trial completion. The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. The outcome measure will be assessed by 6 months after trial completion. The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with hematuria
- Secondary Outcome Measures
Name Time Method To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by cystoscopy alone to establish the true proportion requiring cystoscopy. The outcome measure will be assessed by 6 months after trial completion. To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.
Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology. The outcome measure will be assessed by 6 months after trial completion. Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.
To compare the theoretical clinical outcome of patients tested using Cxbladder tests The outcome measure will be assessed by 6 months after trial completion. To compare the theoretical clinical outcome of patients tested using Cxbladder tests in combination (Triage followed by Detect and / or Resolve) before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.
Performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites The outcome measure will be assessed by 6 months after trial completion. To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015
Trial Locations
- Locations (10)
Veterans Medical Research Foundation
🇺🇸San Diego, California, United States
Bay Pines Veterans Affairs
🇺🇸Bay Pines, Florida, United States
South Florida Veterans Affairs
🇺🇸Miami, Florida, United States
James A Haley Veterans' Hospital
🇺🇸Tampa, Florida, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
NWIHCS-Omaha VA Medical Center
🇺🇸Omaha, Nebraska, United States
James J. Peters VAMC
🇺🇸New York, New York, United States
Oklahoma City VA Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
White River Junction VAMC
🇺🇸White River Junction, Vermont, United States
Veterans Medical Research Foundation🇺🇸San Diego, California, United States